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By now, most BioJobBlog readers have heard that China is poised to become a world leader in the life sciences. As some of you may already know, over 80 per cent of the worlds active pharmaceutical ingredients (APIs) that are used to produce FDA-approved medicines are synthesized in China and exported to manufacturing facilities throughout the world. Further, not a day goes bye without a press release about a new partnership forged between multinational life sciences companies and a Chinese partner. Finally, the Chinese government is heavily investing in the life science industry in an attempt to manufacture medicines for internal use and to export. 

Therefore, it should come as no surprise that Chinese life sciences companies are hiring. One such company is ShangPharma Corporation. ShangPharma was established in 2002 and has locations in Chengdu and Shanghai, China. It is one of China’s largest contract research organizations and employs over 1,600 persons. The company offers discovery and preclinical development services in both chemistry and biology including API and biologics manufacturing. 

The company is currently looking for a person with a PhD or Masters degree with expertise in CNS and/or cognitive subhuman primates (cymologous and/or rhesus monkeys) models. This is a Group Leader position and the ideal candidate will have a background in pharmacology and neurosurgery. Strong communication skills and the ability to speak and write reports in English are required. Please click here for more information or to apply for the position.

While working in China may not be the first choice for most Americans, it may be ideal for foreign students who trained in the US and have a good command of the English language. Whether you are Chinese or American, a sobering fact to remember is that almost 300,000 American pharmaceutical employees have lost their jobs since 2001; making this one of the worst life sciences job markets in history!

Until next time...

Good Luck and Good Job Hunting!!!!!!

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The clinical trial phase of the drug development process is labor intensive, costly and usually takes the largest amount of time to complete. In the past, most human clinical trials for new molecular entities discovered by American scientists were conducted in the US. However, growing healthcare costs and shortages of “treatment-naive” trial participants have forced drug makers to take the effort global. To that end, many companies now routinely conduct Phase I (safety) and Phase II (proof of principle) trials in Eastern Europe, Latin America and Asia. Moreover, a growing number of pharmaceutical companies are beginning to conduct pivotal Phase III trials in which a majority of participants come from outside of the US.

Last year, a report from the inspector general of the Department of Health and Human Services revealed that in 2008 a whopping 78 percent of all subjects participating in trials to support drug applications submitted to the US Food and Drug Administration were enrolled in foreign sites. Likewise, in Europe, approximately 61 percent of patients in human trials submitted to the European Medicines Agency (EMA) from 2005-2009 were from developing countries. Additionally, 11 percent of the participants were enrolled in studies conducted in Eastern Europe. Poland and Hungary appear to have benefited the most from this trend; the number of Poles involved in trials rose fivefold over the period while Hungary was up almost fourfold.

According to a recent article from Reuters, ClinicalTrials.gov—a public website managed by the National Institutes of Health that tracks current US clinical trials—lists roughly 106,000 human clinical trials that are underway around the world. Approximately 50 percent of these trials are being conducted in the US. Interestingly, at present, only 43 percent of all pivotal Phase III trials are being conducted in the US.  Not surprisingly, China is the beneficiary of the trend and is experiencing exponential growth in the number of clinical trials conducted within its borders. To date, over 2,700 clinical trials have been performed in China and that number is likely to drastically increase over the next five years as Chinese medical and healthcare infrastructure continue to improve.

While outsourcing human clinical trials may be favorable to drug makers, the trend is beginning to anger many American physicians who previously benefited from managing US-based clinical trials. These physicians blame their misfortune on the life sciences industry’s endless pursuit to lower costs and the increasing regulatory bureaucracy and red tape surrounding clinical trial procedures in the US.

In addition to physician anger, outsourcing human clinical trials poses several other problems. First, there is a question of ethics. For example, is it right to test an expensive new drug in a country where locals may never be able to afford it if approved? And, are foreign patients always adequately informed or educated about the potential risks and side effects associated with experimental medicines? Second, can ethnic differences between patients contribute to differences in drug effectiveness and safety? In other words, will Caucasian patients respond to a new drug in the same ways as Asian patients? Finally, in the absence of rigorous regulatory inspections can Good Clinical Practices be routinely maintained across all global clinical trial sites? To that end, as pointed out in the Reuters article from 2005 to 2009 EMA inspectors only conducted 44 good clinical practice inspections (outside of the US and Europe) from a total of 44,034 clinical sites. Meanwhile, during the same period, the US FDA inspected only 0.7 percent of foreign clinical trial sites as compared with 1.9 percent of domestic sites.

Like it or not, outsourcing of human clinical trials in emerging markets is a trend that is likely here to stay. Hopefully, in the future, regulatory agencies will be able to better oversee foreign human clinical trials to insure that the drugs that they approve continue to be safe and efficacious.

Until next time...

Good Luck and Good Job Hunting!!!!!!!!!

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The Japanese drug maker Eisai, Co announced that it will cut at least 900 jobs over the next five years to improve operating margins to offset the impending lost of patent protection for Aricept its blockbuster Alzheimer’s  disease treatment. The company did not specify where the cuts would take place.

In other news, based Eli Lilly & Co announced plans to outsource its R&D bioanalytical functions to Advion Biosciences a contract research organization that is building new laboratories Lilly’s home town of Indianapolis, Indiana. Ithaca NY-based Advion is building a 22,000 sq ft facility that will focus on ADME and toxicology experiments that are required for new molecules to enter human clinical testing.

Advion offers a range of Good Laboratory Practice-compliant and discovery bioanalytical services, including liquid chromatography-tandem mass spectrometry (LC/MS/MS) for determining small-molecule drugs, macromolecule therapies and biomarkers; immunoassay services; ADME (absorption, distribution, metabolism, and excretion) screening; cytochrome P450 inhibition and induction study support; metabolism profiling; metabolite identification; sample management; and sample storage.

According to a press release:

 “Lilly will transition its own drug discovery bioanalytical capabilities to Advion and will offer employees affected by the move the opportunity to join Advion. The new laboratory is expected to be fully operational by the end of May 2011.”

This is another example of big pharmaceutical companies exiting the R&D space. Because of the rampant downsizing and outsourcing of R&D functions to CROs, now could be one of the better times in years to start a biotech company. Big pharma is relying on starts up companies and academic laboratories to be the major source of new molecules that they develop. That said, the age of big “in-house” drug discovery operations at big pharmaceutical companies is drawing to an end. 

Until next time...

Good Luck and Good Job Hunting!!!!!!!!!!!!!!!!

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The increasing costs of conducting human clinical trials and the requirement for more stringent safety data for new molecular entities is forcing a growing number of pharmaceutical and biotechnology companies to outsource clinical development of new drugs to Central and Eastern Europe and Asia, most notably India. If your company is considering this option, you may be interested in attending an upcoming conference and workshop sponsored by Next Level Pharma. 

 “Clinical Outsourcing Alliances in Central & Eastern Europe” is a one day conference that will be held on October 8, 2009 in Boston, MA. Company representatives from American and European life science companies and clinical research organization will present talks on the “nuts and bolts” of setting up and conducting human clinical trials in Europe.

A half-day workshop entitled “Clinical Outsource Alliances in India” is being offered on day 2 of the conference. The workshop is intended to introduce American clinical trial sponsors interested in conducting human clinical trials in India to prospective Indian CROs. Presentations from American pharmaceutical executives and Indian CRO representatives will describe the realities of running clinical trials in India and allow attendees to identify potential clinical development partners.

Don’t miss this opportunity to learn the “ins” and “outs of outsourcing foreign clinical drug development.

Until next time...

Good Luck and Good Job Hunting!!!!!

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For those of you who haven’t been able to keep up with the latest pharma layoffs, I came across an article in the Philadelphia Business Journal that does an excellent job of recapping all of the major life sciences layoffs that have taken place in the past year or so. The recent massive pharma layoffs prompted William Ashton, Acting Dean of the University of the Sciences in Philadelphia PA to say “I was in the pharmaceutical industry for 28 years. I’ve never seen such a sea change as is occurring right now. This is really dramatic.” Further, Dr. Ashton predicted that drug companies will increase their use of contract sales forces (CSFs) and contract research organizations (CROs) to contain expenses and that staffing firms will be the winners.

This led to me to wonder what Dean Ashton has been doing for the past 10 years or so because the life sciences industry has already increased its reliance on CROs and CSFs. A quick perusal of the pharma and biotech employees who lost their jobs over the past few years reveals that a majority of them were in sales and R&D. I don’t know whether or not I should break the news to Dean Ashton, but the future is already upon us—another example of how out of touch academia is with industry in the 21^st century.

I think that it is time for industry executives and academicians to begin a serious dialog to determine the type of training that would be appropriate for individuals seeking jobs in the life sciences industry. A failure to do so will likely have a negative adverse effect on the continued growth and future success of the US life science industry.

Until next time…

Good Luck and Good Job Hunting!!!!!

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As you all know by now, American pharmaceutical companies have been intermittently laying off thousands of employees for the past two years or so. Many of the employees who have lost their jobs are R& D scientists, marketing personnel and sales representatives. This seemingly makes sense—because fewer drugs are being discovered and brought to market, fewer people are required to market and sell them. That said, isn’t discovering new drugs the currency and lifeblood of the pharmaceutical industry? How do these companies plan to stay in business if they continue to layoff employees who are seemingly responsible for developing new sources of revenue for them? Taking their cues from the IT and software industries, many US drug makers are beginning to either transfer R&D operations to foreign, company-owned research facilities or outsourcing some or all R&D activities to foreign contract research organizations (CROs).

For those of you who may not know, US pharmaceutical companies have been routinely outsourcing various aspects of R&D and drug manufacturing for many years. For example, a majority of the active pharmaceutical ingredients (APIs) and excipients found in many drug sold in the US are routinely manufactured in places like China, India and elsewhere. Until recently, many pharmaceutical companies were reluctant to outsource many critical R&D activities, e.g., screening, medicinal chemistry, pre-clinical testing, etc. for fear of inferior quality. However, the increasing costs of conducting US-based R&D coupled with a worldwide glut of American-trained, foreign scientists (who were unable or not permitted to find jobs in the US) has made the practice of outsourcing R&D operations less risky and more economically feasible. After all, many of the scientists who work in company-owned foreign research facilities or foreign-owned CROs were trained by American scientists who work at some of America’s pre-eminent academic and government research institutions.

From a business perspective, it makes complete sense that pharmaceutical companies might opt to transfer or outsource R&D operations to foreign countries—the quality is good and it is much cheaper! That said, don’t expect the price of pharmaceutical drugs to plummet anytime soon as more drug makers outsource or expand their R&D operations in foreign countries. Put simply, pharmaceutical companies are outsourcing R&D to cut costs, drive up stock share prices and insure financial growth by preserving the staggering product profit margins that they currently enjoy. Take Bristol-Myers Squibb (BMS) for example. Late last Wednesday, its CFO told a group of financial analysts and investors that the company plans on trimming $2.5 billion by 2012 from its operating budget through US job cuts and revamping operations. Shortly after the announcement, I read with amazement that BMS is expanding its R&D operations in Bangalore, India and that they are looking to hire no fewer than five new Department heads—America’s loss is India’s gain!

While outsourcing or expanding R&D operations in foreign countries at the expense of American workers may help the bottom line of many US drug makers, it will do precious little to reverse the decade-long, decline of America’s global competitiveness in science and technology.

Until next time…

Good Luck and Good Job Hunting (try India)!!!!!!

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